Industry Insights

The global pyrogen testing market size was valued at over USD 621.8 million in 2016 and is projected to grow at 13.4% over the forecast period. Increasing demand for pyrogen testing products in pharmaceutical and biotechnology industry is a major factor contributing towards the growth of the market. Rapidly growing pharmaceutical and biotechnology industries along with escalating number of new therapeutics launch is expected to boost the demand for pyrogen testing products.

Rising investment in R&D by manufacturing companies and government for new product development is another major factor contributed towards the growth of the market. New product development and launch is a key strategy acquired by manufacturers to maintain their dominance and to get maximum revenue-share in the sector. As stated by European Federation of Pharmaceutical Industries and Associations (EFPIA), in Europe, pharmaceutical industry had invested around USD 43,380 million in R&D in 2014. Thus, the demand for pyrogen testing products is expected upsurge in near future, which is projected to boost market growth.

U.S. pyrogen testing market, by product, 2014 - 2025 (USD Million)

Product Insights

On the basis of product, the pyrogen testing industry is segmented into consumables, instruments, and services. In 2016, consumables segment was the largest revenue-generating segment and is also estimated to maintain its dominance during the forecast period. Rising prevalence of chronic diseases boosts the production of pharmaceuticals, biologics, and medical devices products. Thus, the increasing production of these products propels the application of pyrogen testing consumables including kits and reagents.

The instruments segment is expected to show lucrative growth during the forecast period owing to the technological advancement in products. For instance, the PyroDetect System is a verified non-animal substitute to replace the rabbit test that offers a high quality in vitro detection of both non-endotoxin and endotoxin contamination. In 2016, instruments segment was followed by services in terms of revenue.

Test Type Insights

Based on test type, the pyrogen testing industry has been segmented into LAL tests, in vitro tests, and rabbit tests. LAL test is further categorized into turbidimetric test, chromogenic test, and gel clot test. LAL tests is expected to showcase fastest growth during forecast period due to rising demand for animal-free detection tests along with its high reliability and reproducibility during detection.

Rabbit pyrogen test was the most commonly used pyrogen testing method. However, the increasing application for animal-free tests is a predominant factor that could hinder the use of this test type to some extent in near future. The popularity of animal-free tests is increasing because of its ability to assess the product without harming living organisms.

End-Use Insights

The pharmaceutical and biotechnology companies dominated the overall market in 2016 due to the rising production of pharmaceutical, biopharmaceuticals and other biologic products. Hence, the increasing need of pyrogen testing consumables and instruments in these companies propels growth of the market.

Medical devices companies segment is expected to witness the significant growth over the forecast period. The introduction of technologically advanced products and rising demand for high quality medical devices for therapeutic and diagnostics application is anticipated to increase usage of pyrogen testing in the near future.

North America pyrogen testing market share, by end-use, 2016 (%)

Regional Insights

North America dominated the market with the largest revenue share, owing to presence of many large biotechnology and biopharmaceutical firms such as Pfizer Inc., F. Hoffmann-La Roche AG, Merck Group, Celgene Corp. and Amgen Inc. in this region. Also, the highly developed healthcare & research infrastructure and large focus on new drug development in North America have fueled the regional market growth.

Asia Pacific is projected to exhibit highest growth rate during the forecast period, owing to untapped opportunities in this region. There are many manufacturers, targeting Asian countries, such as China & India for drug discovery, development, and production. In addition, the clinical research organizations are focusing on Asian countries for clinical trials. The availability of less stringent government regulations for drug development, vast genome pool, and rapidly developing healthcare infrastructure in this region are some of the major factors responsible for the growth of the sector in this region.

Competitive Insights

Some of the key players in the market are Merck KGaA; GenScript; Hyglos GmbH; Ellab A/S; Lonza; Thermo Fisher Scientific, Inc.; Charles River Laboratories, Inc.; Associates of Cape Cod, Inc.; and Pyrostar. The major companies are undertaking various strategies initiatives, such as new product development, mergers, acquisitions, collaborations, and regional expansion for serving the unmet needs of their customers.

Strategic collaborations or acquisitions help vendors to expand their existing product portfolio and geographical reach. For instance, in July 2013, Hyglos GmbH announced that it has entered into a new partnership with Bioclass S.r.l. for selling Hyglos endotoxin removal systems and endotoxin detection assays in Italy.

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Segments Covered in the Report

This report forecasts revenue growth at global, regional & country levels and provides an analysis on the latest trends and opportunities in each of the sub-segments from 2014 to 2025. For the purpose of this study, Grand View Research has segmented the pyrogen testing market on the basis of product, test type, end-use, and region: